Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
Our department develops analytical methods for the analysis and characterization of neurotoxin biologics for CMC development. As a member of the Bioassay and Molecular Biology team you will contribute directly to our efforts in developing novel assays and improving the platform methods for our pipeline.
What Your New Manager Wants You To Know
The Scientist is responsible for the analysis and characterization of neurotoxin and biologics entities to support the development, qualification, transfer, and validation of analytical methods with experience required in the following:
- Cell-based potency assay (bioassay) and qELISA
Experience in either of the following is a plus:
- Separation techniques including HPLC (RP, SEC, HILIC, IEX), gel and capillary electrophoresis (SDS-PAGE, CE, cIEF)
- Characterization techniques such as mass spectrometry and biophysical-based characterization methods (UV-vis, fluorescence, light scattering, subvisible particle analysis, CD, AUC, DSC, ITC)
Knowledge in cGMP regulations and hands-on cGMP experience are also desired.
He/She independently plans experimental work and executes protocols in support of biologics process development, formulation development, and stability studies. The individual independently generates, compiles, and evaluates data for technical reports to support regulatory filings for new and currently marketed biological products. The individual is also responsible for writing sections or subsections of technical reports, method or operational SOPs. He/She independently carries out multiple analytical methods to support Abbvie biologics projects depending on departmental needs. Maintains a productive and collaborative laboratory environment consistent with regulatory and company expectations.
The position requires the individual to work with and in areas requiring select agents and toxins access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
- Execute the development and validation of analytical methods for the analysis and characterization of biopharmaceuticals. Create written procedures and protocols. Transfer, qualify or validate methods as needed.
- Apply routine and specialized analytical techniques to characterize and quantify biopharmaceuticals. Maintain reagent supplies, notebooks, summarizes results in written reports and communicates observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
- Actively participate on cross-functional teams within Biologics Development and provide support to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
- Develop protocols and SOPs, train staff and maintain the laboratory consistent with departmental and company requirements. Understand, document, and adjust Quality Systems to match the project stage (e.g. pre-development or development).
- Maintain a good and current knowledge of the scientific and technical literature pertinent to the project and necessary for development of state-of-the-art analytical methods, including the acquisition of necessary equipment.
- Keep up-to-date on current and cutting-edge developments in the biologics characterization field.
- Make high quality scientific presentations at internal management, regional and national meetings to help advance Abbvie’s image as the thought and product leader in the neuromodulator field. Present and defends product, assay and process data to regulatory agencies.
- Experience obtained through a combination of appropriate education MS degree and 0-3+ years of applied experience. Individuals with a BS degree and 3 or more years of applied experience may also qualify.
- Extensive experience is required with the application of cell culture, molecular biology, immunoassay, and bioassay techniques for the characterization of proteins and their degradation and modification products. Experience with separation, mass spectrometric, and biophysical techniques is a plus.
- Understanding in CMC development strategy of biologics drugs is expected.
- A solid understanding of methods and procedures related to the production and characterization of biopharmaceuticals in a regulated environment is expected.
- A strong analytical and instrument skills and a thorough understanding and working knowledge of analytical method development and validation.
- Working knowledge of the requirements of working in a cGMP environment is desired.
In this role, we’re looking for a leader who will:
- Act as an Owner
- Be Excellence Focused
- Act as an Influencer
We Will Give You ‘The Abbvie Edge’
At Allergan, we define an 'edge' as something that sets us apart, gives us an advantage and strengthens us to be better – for our customers, patients, investors and each other. Our 'edge' is our colleagues, and we are committed to making Allergan the best place for them to work and achieve career goals.
How do we do this? We Engage, Develop, and Reward our colleagues.
Engage. From Day 1, you are a bold leader who wants to make an impact. We listen to your ideas and questions, so we can be even better at what we do.
Develop. Learn every day, build new skills every day. We prioritize development, so our leaders are always ready for the next challenge and opportunity.
Reward. Exceptional performance creates exceptional opportunities and rewards. Financial awards and incentives are just a part of this - we invest in our people; celebrate success through recognition programs; and promote healthy lifestyles and work-life balance.
Applicable to California Applicants Only
· The below range is the range that we in good faith believe is the range of possible compensation for this role at the time of this posting. We may ultimately pay more or less than the posted range and this range is only applicable for jobs to be performed in California.
This range may be modified in the future.
· The salary range is (minimum: _$66,500 to maximum:_$130,000)
· This job is eligible to participate in our short-term incentive program
· This job is eligible to participate in our long-term incentive programs
· We offer comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.
- Note: No amount of pay is considered to be wages or compensation until such amount is earned, vested, and determinable. The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefits that are allocable to a particular employee remains in the Company's sole discretion unless and until paid and may be modified at the Company’s sole discretion, consistent with the law.
AbbVie is an equal opportunity employer including disability/vets. It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person’s relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.